Limits...
Automated inter-rater reliability assessment and electronic data collection in a multi-center breast cancer study.

Thwin SS, Clough-Gorr KM, McCarty MC, Lash TL, Alford SH, Buist DS, Enger SM, Field TS, Frost F, Wei F, Silliman RA - BMC Med Res Methodol (2007)

Bottom Line: There remains a need to examine potential benefits, efficiencies, and innovations associated with an EDC system in a multi-center medical record review study.Automation of EDC accelerated the flow of study information and resulted in an efficient data collection process.Data collection time was reduced by approximately four months compared to the project schedule and funded time available for manuscript preparation increased by 12 months.

View Article: PubMed Central - HTML - PubMed

Affiliation: Geriatrics Section, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA. sst@bu.edu

ABSTRACT

Background: The choice between paper data collection methods and electronic data collection (EDC) methods has become a key question for clinical researchers. There remains a need to examine potential benefits, efficiencies, and innovations associated with an EDC system in a multi-center medical record review study.

Methods: A computer-based automated menu-driven system with 658 data fields was developed for a cohort study of women aged 65 years or older, diagnosed with invasive histologically confirmed primary breast cancer (N = 1859), at 6 Cancer Research Network sites. Medical record review with direct data entry into the EDC system was implemented. An inter-rater and intra-rater reliability (IRR) system was developed using a modified version of the EDC.

Results: Automation of EDC accelerated the flow of study information and resulted in an efficient data collection process. Data collection time was reduced by approximately four months compared to the project schedule and funded time available for manuscript preparation increased by 12 months. In addition, an innovative modified version of the EDC permitted an automated evaluation of inter-rater and intra-rater reliability across six data collection sites.

Conclusion: Automated EDC is a powerful tool for research efficiency and innovation, especially when multiple data collection sites are involved.

Show MeSH

Related in: MedlinePlus

Screen shot of EDC data collection form.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC1919388&req=5

Figure 1: Screen shot of EDC data collection form.

Mentions: We developed a computer-based automated menu-driven EDC system using Microsoft® Access 2000. The "back end" of the system consisted of six tables that stored 658 exported data variables after completion of data abstraction in the "front end" of the system. The "front end" of the system was organized into five forms for collecting information on (1) eligibility, patient characteristics, tumor characteristics, and treatment, (2) diagnosis and treatment of recurrence and second primary cancer, (3) comorbidity at three time points, (4) surveillance testing for recurrent breast cancer after completing primary therapy, and (5) mammography screening. All forms were menu-driven, in a tabular format (as shown in Figure 1), and linked by a unique study subject identification (ID) number. Each site maintained a Microsoft® Excel file that linked each subject's study number in the EDC to the subject's original medical record number to allow local access to electronic data and medical records as needed. Study specific queries and macros were programmed to allow for toggling between the forms, verification of input data, final checking for completeness of the data collected, and for export into the "back-end" database. Consistent with data use agreements between Boston Medical Center and the data collection sites, and per HIPAA agreements, personal identifiers such as surgeons' names and patients' day of birth were deleted before exporting into the "back-end" database.


Automated inter-rater reliability assessment and electronic data collection in a multi-center breast cancer study.

Thwin SS, Clough-Gorr KM, McCarty MC, Lash TL, Alford SH, Buist DS, Enger SM, Field TS, Frost F, Wei F, Silliman RA - BMC Med Res Methodol (2007)

Screen shot of EDC data collection form.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC1919388&req=5

Figure 1: Screen shot of EDC data collection form.
Mentions: We developed a computer-based automated menu-driven EDC system using Microsoft® Access 2000. The "back end" of the system consisted of six tables that stored 658 exported data variables after completion of data abstraction in the "front end" of the system. The "front end" of the system was organized into five forms for collecting information on (1) eligibility, patient characteristics, tumor characteristics, and treatment, (2) diagnosis and treatment of recurrence and second primary cancer, (3) comorbidity at three time points, (4) surveillance testing for recurrent breast cancer after completing primary therapy, and (5) mammography screening. All forms were menu-driven, in a tabular format (as shown in Figure 1), and linked by a unique study subject identification (ID) number. Each site maintained a Microsoft® Excel file that linked each subject's study number in the EDC to the subject's original medical record number to allow local access to electronic data and medical records as needed. Study specific queries and macros were programmed to allow for toggling between the forms, verification of input data, final checking for completeness of the data collected, and for export into the "back-end" database. Consistent with data use agreements between Boston Medical Center and the data collection sites, and per HIPAA agreements, personal identifiers such as surgeons' names and patients' day of birth were deleted before exporting into the "back-end" database.

Bottom Line: There remains a need to examine potential benefits, efficiencies, and innovations associated with an EDC system in a multi-center medical record review study.Automation of EDC accelerated the flow of study information and resulted in an efficient data collection process.Data collection time was reduced by approximately four months compared to the project schedule and funded time available for manuscript preparation increased by 12 months.

View Article: PubMed Central - HTML - PubMed

Affiliation: Geriatrics Section, Department of Medicine, Boston University School of Medicine, Boston, Massachusetts, USA. sst@bu.edu

ABSTRACT

Background: The choice between paper data collection methods and electronic data collection (EDC) methods has become a key question for clinical researchers. There remains a need to examine potential benefits, efficiencies, and innovations associated with an EDC system in a multi-center medical record review study.

Methods: A computer-based automated menu-driven system with 658 data fields was developed for a cohort study of women aged 65 years or older, diagnosed with invasive histologically confirmed primary breast cancer (N = 1859), at 6 Cancer Research Network sites. Medical record review with direct data entry into the EDC system was implemented. An inter-rater and intra-rater reliability (IRR) system was developed using a modified version of the EDC.

Results: Automation of EDC accelerated the flow of study information and resulted in an efficient data collection process. Data collection time was reduced by approximately four months compared to the project schedule and funded time available for manuscript preparation increased by 12 months. In addition, an innovative modified version of the EDC permitted an automated evaluation of inter-rater and intra-rater reliability across six data collection sites.

Conclusion: Automated EDC is a powerful tool for research efficiency and innovation, especially when multiple data collection sites are involved.

Show MeSH
Related in: MedlinePlus